MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain

May 10, 2023 updated by: Istituto Ortopedico Rizzoli

Magnetic Resonance Guided Focused Ultrasound Surgery: a Pilot Study in the Treatment of Pain Caused by Osteoarthritis - Hand and Hip, Challenging Joints

This project aims at performing a pilot study to provide data on safety and potential efficacy of Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) in the treatment of pain caused by trapeziometacarpal osteoarthritis (OA) and/or scaphotrapezial OA, and by hip OA, while exploring the potential application of MRgFUS to two different and central joints burdened by OA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pain caused by osteoarthritis is a matter of huge impact, in terms of quality of life, social and economic burden. Global aging of the population is going to worsen the problem. The hand is the most affected site in the upper limb, and involvement of the trapeziometacarpal joint is highly prevalent, with significant limitation of functionality when it happens. In the lower limb, the hip and the knee share the leading position in the clinical scenario, with the former being historically the most frequently submitted to joint replacement.

At any site, the vast majority of joint replacement surgery procedures are performed because of pain. MRgFUS has recently demonstrated a great potential in treating pain caused by different medical conditions, including osteoarthritis. The aim of the work is to study the feasibility, the safety and the potential efficacy of MRgFUS in treating pain from osteoarthritis in two "hot" spots: the hip and the trapeziometacarpal/scaphotrapezial joint.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female aged between 45 and 90 years
  • Presence of activity-related joint pain
  • Patients who have either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes
  • Patients who have not responded to previous treatments,
  • Patients with a baseline pain intensity of 4 to 8 on a 10-cm VAS
  • Patients who are not candidates for immediate surgery
  • Signed statement of informed consent (approved by Ethics Committee)

Exclusion Criteria:

  • Prior surgery or previous local treatment (infiltration, other) in the past 3 months
  • Changes in medications used during the previous 2 months
  • Intravenous drug use
  • Corticosteroid use of more than 3 months within the preceding year
  • Diagnosis of other rheumatologic disorders
  • Trauma, fracture, or osteomyelitis of the investigated joints within the preceding year
  • Any neurological disease or disorders potentially affecting pain perception
  • Fibromyalgia
  • Pregnancy
  • Patients with large scar at skin or deeper soft tissue potentially included in the planned path of the ultrasound beam
  • General contraindications to MRI and/or to anaesthesiological procedures planned for the patient
  • Presence of internal hardware or devices potentially affecting MR thermometry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hand ExAblate
MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)
Device: MRgFUS treatment
MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)
Device: MRgFUS treatment
MRgFUS treatment of pain caused by hip OA
Experimental: Hip ExAblate
MRgFUS treatment of pain caused by hip OA
Device: MRgFUS treatment
MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)
Device: MRgFUS treatment
MRgFUS treatment of pain caused by hip OA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Pain Intensity from Baseline
Time Frame: Baseline (Day1), Week 1, 2, 3, Month 1, 2, 3, 6, 9, 12
Changes in pain intensity from baseline will be determined by a straight horizontal 10-cm linear Visual Analog Pain Scale (VAS, scale 0-10 where 0 means 'no pain at all' and 10 means 'pain as bad as it could be').
Baseline (Day1), Week 1, 2, 3, Month 1, 2, 3, 6, 9, 12
Incidence of Treatment-Related Adverse Events (Safety and Tolerability)
Time Frame: Through study completion, an average of 1 year
Collecting the number of treatment-related adverse events
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Principal Investigator: Alberto Bazzocchi, MD, PhD, The Rizzoli Ortopaedic Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2019

Primary Completion (Actual)

March 15, 2020

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

February 23, 2018

First Submitted That Met QC Criteria

March 9, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • handhip@IORFus

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis

Clinical Trials on MRgFUS treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe